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Mammomat Revelation — recall 73643

Health Canada — Medical Devices · Canada · 2023-05-11 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 73643
Date of alert: 2023-05-11
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Radiology
Product type: Medical devices

Reported risk: The new software version VC20G provides latest cybersecurity updates and improvements in the following categories: - Improves overall system stability - Improves dicom connectivity - Improves biopsy workflow Specifically, the new software version updates some d icom tags related to pre-fix for spot images and spatial locations preserved. It eliminates lock conflict during tomosynthesis reconstruction and detector connection issues. Updated user messages provide clear guidance during the biopsy procedure. Recall start date: May 2, 2023

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/mammomat-revelation

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Mammomat Revelation — recall 73643

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